The FDA has created a pathway for the approval of biosimilar products, but has not yet approved a biological product as biosimilar or interchangeable. There is no date-certain for when these products will be approved—some estimates are three to five years.
The Board of Pharmacy has established a link on its website to the FDA pathway for approval of biosimilar biological products.
FDA information regarding Biosimilars
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Posted in Latest News on August 26, 2013.